Google’s venture arm recruits a Harvard/Tesaro vet to help plant the seeds for a second oncology R&D revolution

Sridhar Ramaswamy. GV

October 28, 2019 08:59 AM EDTUpdated 09:10 AM

Google’s venture arm recruits a Harvard/Tesaro vet to help plant the seeds for a second oncology R&D revolution

John Carroll

Editor & Founder

Oncology R&D has been exploding over the past 5 years, and now Google’s venture arm is preparing to place a few explosives to help with the revolution — relying on a new recruit in the Cambridge/Boston branch to assist in fostering the movement.

Eight months after the high-profile scientist and Agios founder David Schenkein started his third career act in biotech, teaming up with Krishna Yeshwant as a general partner in charge of the life sciences portfolio at GV, they’re bringing on board their second entrepreneur-in-residence to help strategize their approach to investing in cancer research. And he has some deep experience in the oncology field.

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Biogen CEO Michel Vounatsos (via Getty Images)

November 27, 2020 09:56 AM EST

Deals

With aducanumab caught on a cliff, Biogen’s Michel Vounatsos bets billions on another high-risk neuro play

John Carroll

Editor & Founder

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

November 25, 2020 11:48 AM EST

Coronavirus

Manufacturing

After Kodak debacle, US lends $1.1B to a synthetic biology company and their big Covid-19, mRNA plans

Jason Mast

Associate Editor

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Pascal Soriot (AP Images)

November 23, 2020 05:43 AM ESTUpdated 02:00 PM

Coronavirus

UPDATED: AstraZeneca, Oxford on the defensive as skeptics dismiss 70% average efficacy for Covid-19 vaccine

Amber Tong

Editor

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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November 25, 2020 06:56 AM ESTUpdated 11:18 AM

Coronavirus

Covid-19 roundup: Europe purchases 80M doses of Moderna's vaccine; COVAXX secures $2.8B in emerging market pre-orders

Max Gelman

Associate Editor

Nicole DeFeudis

Associate Editor

Amber Tong

Editor

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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November 24, 2020 08:37 AM EST

Bioregnum

Regulatory

The aducanumab conundrum: The PhIII failed a clear regulatory standard, but no one is certain what that means anymore at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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November 25, 2020 11:31 AM ESTUpdated 03:22 PM

Regulatory

Coronavirus

FDA hands Liquidia and Revance a CRL and deferral, respectively, as Covid-19 creates inspection challenge

Nicole DeFeudis

Associate Editor

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

November 25, 2020 11:25 AM EST

News Briefing

News briefing: FDA requests new trial for Reata's Friedreich's ataxia program; J&J's Tremfya picks up expanded label in Europe

Max Gelman

Associate Editor

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

November 25, 2020 11:12 AM EST

Peer Review

Jeffrey Hatfield takes over from Diego Miralles as CEO of Vividion; Dragonfly scores a new exec with COO Alex Lugovskoy

Alex Hoffman

Assistant Editor

Kathy Wong

Assistant Editor

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

November 25, 2020 11:07 AM EST

IPOs

China

China opens the door for biotech investors in Hong Kong to buy Shanghai stocks, and vice versa

Amber Tong

Editor

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.